Uterine Manipulators and Related Components and Methods

ABSTRACT

A uterine manipulator includes a shaft configured to be inserted into a cervix and a colpotomizer assembly configured to move along the shaft. The shaft includes multiple ruler markings printed along a portion of the shaft. The colpotomizer assembly includes a sleeve that includes a rotatable locking member configured to compress the shaft in a manner that locks the colpotomizer assembly in position along the shaft when the rotatable locking member is depressed against the shaft. The rotatable locking member includes a cam roller configured to compress the shaft when the rotatable locking member is depressed towards the shaft.

TECHNICAL FIELD

This disclosure relates to uterine manipulators and related componentsand methods.

BACKGROUND

Uterine manipulators are medical instruments that are used formanipulating (e.g., moving or repositioning) a patient's uterus duringmedical procedures. Such procedures include surgical procedures, such aslaparoscopic gynecologic surgery (e.g., total laparoscopic hysterectomy(TLH) surgery). Instruments of this kind often include a proximalportion that remains external to the patient's body during use and adistal portion that is inserted into the patient's body. The proximalportion typically provides for manipulation of the instrument duringuse. The distal portion often includes a tip that is sized to beinserted into and/or engage the uterus. Generally, the distal portion ofthe instrument is advanced through the vaginal cavity and into theuterus. With the distal portion inserted within a uterus, the uterus canbe manipulated through surgeon-controlled or physician-controlledmovements of the proximal portion. Following completion of a procedure,the instrument is removed from the patient's body via the vaginalcavity.

SUMMARY

In general, this disclosure relates to uterine manipulators and relatedcomponents and methods. Such uterine manipulators can be used formanipulating a patient's uterus during gynecological surgery and/orgynecological diagnostic procedures.

In one aspect, a uterine manipulator includes an arcuate shaftconfigured to be inserted into a cervix and a colpotomizer assemblyconfigured to move along the arcuate shaft. The colpotomizer assemblyincludes a cup configured to receive the cervix. The cup defines a cupface disposed substantially perpendicular to an axial centerline of thecup and having a centerpoint disposed along the axial centerline of thecup, and an opening spaced apart from the cup face and sized to allowpassage of the arcuate shaft. The opening is configured such that, whenthe arcuate shaft is positioned within the opening, an arcuatecenterline of the arcuate shaft is aligned with the centerpoint of thecup face, and the arcuate centerline of the arcuate shaft is offset fromthe axial centerline of the cup at the opening.

In another aspect, a colpotomizer assembly includes a cup configured toreceive a cervix. The cup defines a cup face disposed perpendicular toan axial centerline of the cup and having a centerpoint disposed alongthe axial centerline of the cup and an opening spaced apart from the cupface and sized to allow passage of a shaft. The opening is configuredsuch that, when the shaft is positioned within the opening, an arcuatecenterline of the shaft is aligned with the centerpoint of the cup face,and the arcuate centerline of the shaft is offset from the axialcenterline of the cup at the opening.

In a further aspect, a method of adjusting a uterine manipulatorincludes moving a colpotomizer cup of the uterine manipulator along acurved shaft of the uterine manipulator in a manner such that a distalface of the colpotomizer cup remains centered on an arch centerline ofthe curved shaft and an axial centerline of the colpotomizer cup remainsoffset from the arch centerline of the curved shaft at an opening of thecolpotomizer cup that is spaced proximally from the distal face of thecolpotomizer cup.

In a further aspect, a uterine manipulator includes a shaft configuredto be inserted into a cervix. The shaft includes multiple ruler markingsprinted along a portion of the shaft and a colpotomizer assemblyconfigured to move along the shaft. The colpotomizer assembly includes asleeve that includes a rotatable locking member configured to compressthe shaft in a manner that locks the colpotomizer assembly in positionalong the shaft when the rotatable locking member is depressed againstthe shaft. The rotatable locking member includes a cam roller configuredto compress the shaft when the rotatable locking member is depressedtowards the shaft.

In a further aspect, a colpotomizer assembly configured to move along ashaft of a uterine manipulator includes a sleeve that includes arotatable locking member configured to compress the shaft in a mannerthat locks the colpotomizer assembly in position along the shaft whenthe rotatable locking member is depressed against the shaft. Therotatable locking member includes a cam roller configured to compressthe shaft when the rotatable locking member is depressed towards theshaft.

In a further aspect, a method of adjusting a uterine manipulatorincludes moving a colpotomizer sleeve of the uterine manipulator to apredetermined position along a shaft of the uterine manipulator,depressing a rotatable locking member of the colpotomizer sleeve towardsthe shaft, compressing the shaft with the rotatable locking member ofthe colpotomizer sleeve to lock the colpotomizer sleeve at thepredetermined location, and confirming an accuracy of the position ofthe colpotomizer sleeve by visualizing a ruler marking printed along theshaft using a magnification lens of the rotatable locking member.

In a further aspect, a uterine manipulator includes a shaft configuredto be inserted into a cervix, the shaft defining a central lumen thatpasses air between a proximal portion of the shaft and a distal tip ofthe shaft. The uterine manipulator further includes an expandableballoon secured to the distal tip of the shaft and a handle secured tothe proximal portion of the shaft. The handle includes an integralsyringe that is configured to inflate and deflate the expandable balloonby displacing air within the central lumen of the shaft.

In a further aspect, a method of deploying a uterine manipulatorincludes inserting a shaft of the uterine manipulator through a cervix,actuating an integral syringe within a handle that is secured to aproximal portion of the shaft, and inflating an expandable balloon thatis secured to a distal tip of the uterine manipulator.

Implementations may provide one or more of the following features.

In some embodiments, the arcuate shaft includes a proximal portion, acentral portion along which the colpotomizer assembly can move, and adistal tip.

In certain embodiments, the arcuate shaft is a rigid shaft.

In some embodiments, the cup includes a cup body that defines the cupface at a distal end of the cup.

In certain embodiments, the cup body is configured to receive thecervix.

In some embodiments, the cup body defines multiple viewing windows forvisualizing the cervix within the cup body.

In certain embodiments, the cup body defines a beveled rim configured toprovide an anatomical landmark and an incision backstop.

In some embodiments, the cup includes a base defining the opening.

In certain embodiments, when the arcuate shaft is disposed within theopening, the arcuate centerline of the arcuate shaft is offset by about0.065 inch to about 0.085 inch from the axial centerline of the cup atthe opening.

In some embodiments, the colpotomizer assembly further includes a sleeveconnected to the cup and defining a channel configured to receive thearcuate shaft.

In certain embodiments, the sleeve includes a locking member configuredto lock the colpotomizer assembly at any of multiple different locationsalong the arcuate shaft.

In some embodiments, the colpotomizer assembly further includes avaginal occluder.

In certain embodiments, the uterine manipulator further includes amanipulator handle secured to the arcuate shaft.

In some embodiments, the manipulator handle includes an integratedsyringe configured to displace air within a central lumen of the arcuateshaft.

In certain embodiments, the uterine manipulator further includes anexpandable balloon disposed along a distal tip of the arcuate shaft andin fluid communication with the central lumen of the arcuate shaft.

In some embodiments, the integrated syringe is configured to deliver airto and withdraw air from the expandable balloon.

In certain embodiments, the uterine manipulator further includes anintegrated light source mounted to a distal tip of the arcuate shaft.

In some embodiments, the manipulator handle includes a power source forpowering the integrated light source.

In certain embodiments, the uterine manipulator is a single-use device.

In some embodiments, the uterine manipulator further includes a shrinktube disposed about the arcuate shaft for facilitating movement of thecolpotomizer assembly along the arcuate shaft and locking of thecolpotomizer assembly along the shaft.

In certain embodiments, the cup body defines a recess configured toreceive a cervix.

In some embodiments, the opening is configured to receive an arcuateshaft.

In certain embodiments, the sleeve includes a locking member configuredto lock the colpotomizer assembly at a predetermined location along theshaft.

In some embodiments, the colpotomizer cup includes a body that definesthe distal face.

In certain embodiments, the body defines multiple viewing windows forvisualizing the cervix within the body.

In some embodiments, at the opening of the colpotomizer cup, the axialcenterline of the colpotomizer cup remains offset from the arcuatecenterline of the curved shaft by about 0.065 inch to about 0.085 inch.

In certain embodiments, moving the colpotomizer cup includes moving asleeve that is connected to the colpotomizer cup.

In some embodiments, the sleeve defines a channel configured to receivethe curved shaft.

In certain embodiments, the method further includes locking thecolpotomizer sleeve at a predetermined location along the curved shaft.

In some embodiments, the shaft is a rigid shaft.

In certain embodiments, the uterine manipulator further includes ashrink tube that surrounds a portion of the shaft, such that when therotatable locking member is depressed towards the shaft, the rotatablelocking member compresses the shrink tube.

In some embodiments, the shrink tube has a hardness of about shore D25to about shore D60.

In certain embodiments, the sleeve defines a channel configured toreceive the shaft.

In some embodiments, the rotatable locking member includes a lensconfigured to magnify a ruler marking of the multiple ruler markingswhen the rotatable locking member is depressed against the shaft.

In certain embodiments, the rotatable locking member includes a rollermount that extends from the cam roller, and the sleeve defines areceptacle configured to receive the roller mount of the rotatablelocking member.

In some embodiments, the sleeve includes opposing projections, and therotatable locking member includes a jaw configured snap fit onto theopposing projections for securing the rotatable locking member in alocked configuration.

In certain embodiments, the rotatable locking member includes a liftflange for rotating the rotatable locking member away from the shaft andinto an open configuration.

In some embodiments, the multiple ruler markings indicate a distancebetween a base of a cup of the colpotomizer assembly and a distal end ofthe shaft.

In some embodiments, the colpotomizer assembly further includes a cupconfigured to receive the cervix and that is attached to the sleeve.

In certain embodiments, the cup is configured such that a distal face ofthe cup remains centered on an arch centerline of the shaft as thecolpotomizer assembly is moved along the shaft and such that an axialcenterline of the cup remains offset from the arch centerline of theshaft at an opening of the cup that is spaced proximally from the distalface of the cup.

In certain embodiments, the uterine manipulator further includes amanipulator handle.

In some embodiments, the manipulator handle includes an integratedsyringe configured to displace air within a central lumen of the shaft.

In certain embodiments, the uterine manipulator further includes anexpandable balloon disposed along a distal tip of the shaft and in fluidcommunication with the central lumen of the shaft.

In some embodiments, the sleeve defines a channel that surrounds theshaft.

In certain embodiments, the rotatable locking member includes a lensconfigured to magnify a ruler marking printed along the shaft when therotatable locking member is depressed against the shaft.

In some embodiments, the ruler marking indicates a distance between abase of a cup of the colpotomizer assembly and a distal end of theshaft.

In certain embodiments, the rotatable locking member includes a rollermount that extends from the cam roller, and the sleeve defines areceptacle configured to receive the roller mount of the rotatablelocking member.

In some embodiments, the cup is configured such that a distal face ofthe cup remains centered on an arch centerline of the shaft as thecolpotomizer assembly is moved along the shaft and such that an axialcenterline of the cup remains offset from the arch centerline of theshaft at an opening of the cup that is spaced proximally from the distalface of the cup as the cup is moved along the shaft.

In certain embodiments, the colpotomizer sleeve defines a channelconfigured to receive the shaft.

In some embodiments, compressing the shaft with the rotatable lockingmember includes rotating a cam roller of the rotatable locking memberinto a shrink tube surrounding the shaft.

In certain embodiments, depressing the rotatable locking member towardsthe shaft includes rotating a roller mount of the rotatable lockingmember within receptacles of the colpotomizer sleeve.

In some embodiments, compressing the shaft with the rotatable lockingmember includes snap fitting a jaw of the rotatable locking member ontoopposing projections of the colpotomizer sleeve for securing therotatable locking member in a locked configuration.

In certain embodiments, the method further includes moving a lift flangeof the rotatable locking upwards for rotating the rotatable lockingmember away from the shaft and into an open configuration.

In some embodiments, the ruler marking indicates a distance between abase of a colpotomizer cup secured to the colpotomizer sleeve and adistal end of the shaft.

In certain embodiments, moving the colpotomizer sleeve along the shaftincludes moving a colpotomizer cup configured to receive a cervix andthat is attached to the colpotomizer sleeve.

In some embodiments, the colpotomizer cup is configured such that adistal face of the colpotomizer cup remains centered on an archcenterline of the shaft as the colpotomizer cup is moved along the shaftand such that an axial centerline of the cup remains offset from thearch centerline of the shaft at an opening of the cup that is spacedproximally from the distal face of the cup as the colpotomizer cup ismoved along the shaft.

In certain embodiments, the moving, the depressing, and the compressingis performed in a one-handed process.

In some embodiments, the integral syringe includes a body and a plungerconfigured to move within the body to displace air.

In certain embodiments, a proximal portion of the shaft extends into thebody of the plunger.

In some embodiments, the plunger includes a button that is slidablealong the handle.

In certain embodiments, the expandable balloon is inflated when thebutton is moved distally, and the expandable balloon is deflated whenthe button is moved proximally.

In some embodiments, the integral syringe includes one or more detentsthat maintain the button in a proximal or a distal position.

In certain embodiments, the shaft defines an opening that passes airbetween the central lumen of the shaft and the expandable balloon.

In some embodiments, the handle defines multiple depressions thattogether provide a grip for grasping the handle.

In certain embodiments, the uterine manipulator further includes anintegrated light source mounted to the distal tip of the shaft.

In some embodiments, the power source includes one or more electricalwires that extend within the central lumen of the shaft from the powersource to the integrated light source.

In certain embodiments, the integrated light source is an LED.

In some embodiments, the uterine manipulator further includes acolpotomizer assembly that is movable along the shaft.

In certain embodiments, the colpotomizer assembly includes a cup that isconfigured to receive a cervix.

In some embodiments, the cup is configured such that a distal face ofthe cup remains centered on an arch centerline of the shaft as the cupis moved along the shaft and such that an axial centerline of the cupremains offset from the arch centerline of the shaft at an opening ofthe cup that is spaced proximally from the distal face of the cup as thecolpotomizer assembly is moved along the shaft.

In certain embodiments, the colpotomizer assembly includes a sleeve thatis configured to lock the colpotomizer assembly in position along theshaft.

In some embodiments, the shaft is a rigid cannula.

In certain embodiments, the shaft is a curved shaft.

In some embodiments, the method further includes determining a depth ofa uterus at which to insert the shaft through the cervix.

In certain embodiments, the shaft defines a central lumen that passesair between the integral syringe and the expandable balloon.

In some embodiments, actuating the integral syringe includes moving aplunger of the integral syringe distally along the handle to deliver airto the expandable balloon.

In certain embodiments, the method includes moving a plunger of theintegral syringe proximally along the handle to withdraw air from theexpandable balloon, and deflating the expandable balloon.

In some embodiments, the shaft defines an opening that passes airbetween the central lumen of the shaft and the expandable balloon.

In certain embodiments, the method further includes grasping the handlealong multiple depressions defined by the handle.

In some embodiments, the method further includes powering a light sourcemounted to the distal tip of the shaft.

In some embodiments, the method further includes moving a colpotomizerassembly of the uterine manipulator into an operational position.

In some embodiments, the method further includes locking thecolpotomizer assembly along the shaft at the operational position.

Implementations may provide one or more of the following advantages.

In some embodiments, a geometry (e.g., provided by the position and sizeof an opening within a colpotomizer cup base) ensures proper alignmentof a cup face with respect to a shaft of the uterine manipulator. Inparticular, a centerpoint of the cup face is maintained along an archcenterline of the shaft. Such a configuration is imposed by an offsetbetween a centerline of the colpotomizer cup (along which thecenterpoint of the cup face lies) and the arch centerline of the shaft,at the position of the opening in the colpotomizer cup base. Suchalignment of the colpotomizer cup with respect to the shaft ensures thatan appropriately angled cutting edge is achieved for guiding a cuttingof the uterus with an even distribution of tissue when the cervix isreceived within the colpotomizer cup. This geometry prevents positioningof the uterine manipulator with a mis-oriented cutting edge, which couldlead to undesirable effects following the procedure.

In certain embodiments, the uterine manipulator includes a one-handedlocking mechanism that allows a colpotomizer assembly to be locked intoa desired position along a shaft of the uterine manipulator. The lockingmechanism can include a thumb lock that can be actuated with the samehand that moves the colpotomizer assembly along the shaft. The thumblock provides the user with the ability to easily position and lock thecolpotomizer assembly at any of various different positions along theshaft of the uterine manipulator. The thumb lock includes a cam rollerthat has a variable radius, such that the cam roller can compress (e.g.,dig into) a shrink tube as the cam roller is rotated towards the shaftof the uterine manipulator, thereby providing resistance to movement ofthe colpotomizer assembly along the shaft. The mechanical integrity ofthe thumb lock may be maintained over multiple (e.g., four) lock-unlockcycles.

In some embodiments, a convex lens of the thumb lock magnifies rulermarkings printed along the shaft, such that a ruler markingsubstantially fills a viewing window of the lens. Such magnificationassists the user of the uterine manipulator in visualizing the rulermarkings to determine an appropriate position of the colpotomizerassembly along the shaft. Proper placement of the uterine manipulatorwith respect to a fundus of the uterus, as aided by the lens of thethumb lock and the ruler markings along the shaft, can preventperforation and other damage to the fundus and the distal region of theuterus. Furthermore, the alignment of the lens with the ruler markingand the ability to view placement of the cervix within the colpotomizercup through viewing windows helps to ensure that the colpotomizer cup isfully forward in the desired position relative to a distal tip of theshaft and relative to the cervix.

In certain embodiments, a manipulator handle includes an integralsyringe for injecting air into and removing air from a central lumen ofa shaft of the uterine manipulator to inflate and deflate an expandableballoon in fluid communication with the central lumen. Button actuationof the syringe can provide the user with a simple, ergonomic, andone-handed mechanism for inflating and deflating the expandable balloonduring a surgical procedure. Furthermore, finger depressions positionedalong the manipulator handle provide an ergonomic grip for grasping andpositioning the uterine manipulator.

In some embodiments, an integral light source mounted to a distal tip ofa shaft of the uterine manipulator can be used to illuminate the vaginalcavity and external orifice of the uterus (cervical os) during insertionof the uterine manipulator. The light source and the distal tip providean atraumatic surface that allows the uterine manipulator to be insertedin the patient without damaging tissues of the vaginal cavity, cervix,or uterus. The light source can be turned on and off by actuating abutton disposed along a distal region of a manipulator handle andoptimally positioned for a right-handed or left-handed use. Buttonactuation of integral light source can provide the user with a simple,ergonomic, and one-handed mechanism for increasing visibility duringinsertion of the uterine manipulator.

In some embodiments, materials (e.g., 304 SS or 304 SS full hard) fromwhich a shaft of the manipulator is constructed can advantageouslyprovide tactile feedback to the user as the shaft is inserted orpositioned within the patient. Certain portions of the shaft are coveredby a shrink tube that provides lubricity for sliding of a colpotomizerassembly along the shaft and traction for locking the colpotomizerassembly in a desired position. The shrink tube can have a certainhardness that provides the shrink tube with enough traction to securelylock the colpotomizer assembly in the desired position.

In certain embodiments, the ability to displace a colpotomizer assemblycan allow for quicker and easier positioning of a distal tip of a shaftof the uterine manipulator within the cervix since a procedure can beperformed without visual obstruction of the colpotomizer assembly.

In certain embodiments, the uterine manipulator can be provided as adisposable (e.g., single-use) surgical device.

Other aspects, features, and advantages will be apparent from thedescription, the drawings, and the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a uterine manipulator including amanipulator handle, a shaft, an expandable balloon, a light source, anda colpotomizer assembly.

FIG. 2 is a cross-sectional side view of the uterine manipulator of FIG.1, shown without the colpotomizer assembly.

FIG. 3 is a perspective view of a portion of the uterine manipulator ofFIG. 1, shown with portions of the colpotomizer assembly removed andwith the colpotomizer assembly in an unlocked configuration.

FIG. 4 is a perspective view of a portion of the uterine manipulator ofFIG. 1, shown with portions of the colpotomizer assembly removed andwith the colpotomizer assembly in a locked configuration.

FIG. 5 is a perspective view of a vaginal occluder of the colpotomizerassembly of FIG. 1.

FIG. 6 is a cross-sectional side view of a portion of the uterinemanipulator of FIG. 1.

FIG. 7 is a front perspective view of the colpotomizer assembly of FIG.1.

FIG. 8 is a perspective view of the uterine manipulator of FIG. 1provided in a packaging container.

FIG. 9 is a cross-sectional side view of a pelvic cavity showing theuterine manipulator of FIG.1 in a fully inserted position and with thecolpotomizer assembly in a loading position.

FIG. 10 is a cross-sectional side view of the pelvic cavity of FIG. 9,showing the uterine manipulator of FIG. 1 in a fully inserted position,with the expandable balloon inflated, and with the colpotomizer assemblyunlocked in the loading position.

FIG. 11 is a cross-sectional side view of the pelvic cavity of FIG. 9,showing the uterine manipulator of FIG. 1 fully inserted, with thecolpotomizer assembly locked in an operational position.

FIG. 12 is a cross-sectional side view of the pelvic cavity of FIG. 9,showing the uterine manipulator of FIG. 1 supporting a uterus.

DETAILED DESCRIPTION

FIG. 1 illustrates a uterine manipulator 100 adapted for insertion intoa vaginal cavity for use in female pelvic surgical procedures. Theuterine manipulator 100 includes a shaft 102 configured to extend withina cervix for use in repositioning a uterus and a colpotomizer assembly104 disposed about the shaft 102 and configured to receive the cervix.The uterine manipulator 100 further includes an expandable balloon 106secured to a distal tip 108 of the shaft 102 and configured to maintaina position of the distal tip 108 within the uterus. A light source 110is mounted to the distal tip 108 of the shaft 102 and can be used toilluminate the vaginal cavity and external orifice of the uterus (i.e.,the cervical os) during insertion of the uterine manipulator 100. Amanipulator handle 112 is connected to a proximal portion 114 of theshaft 102.

Referring to FIG. 2, the shaft 102 of the uterine manipulator 100 isformed as a rigid cannula that has a generally curved (e.g., arcuate)shape. The shaft 102 includes the proximal portion 114 that extends intothe manipulator handle 112, a central portion 116 along which thecolpotomizer assembly 104 is displaceable for engaging the cervix, andthe distal tip 108 configured to extend through the cervix and into theuterus. The central portion 116 and a section of the proximal portion114 that extends distally from the manipulator handle 112 are covered bya shrink tube 118 that provides lubricity for sliding of thecolpotomizer assembly 104 along the shaft 102 and traction for lockingthe colpotomizer assembly 104 in a desired position along the shaft 102,as will be discussed in more detail with respect to FIG. 4. The shrinktube 118 typically has a thickness of about 0.010 inch to about 0.020inch (e.g., about 0.014 inch to about 0.018 inch).

The shaft 102 of the uterine manipulator 100 defines a central lumen 120that allows passage of air between the manipulator handle 112 and theexpandable balloon 106. The central lumen 120 of the shaft 102 alsoallows passage of one or more electrical wires 117 from a power source115 (e.g., a battery) disposed within the manipulator handle 112 to thelight source 110 secured to the distal tip 108 of the shaft 102. Theshaft 102 also defines an opening 122 located along the distal tip 108that allows passage of air between the central lumen 120 and theexpandable balloon 106 for inflating and deflating the expandableballoon 106. The shaft 102 further includes a set of ruler markings 124(shown in FIGS. 1 and 3) printed across the shrink tube 118 along thecentral portion 116 and that indicate a distance from the fundus of theuterus when the uterine manipulator 100 is appropriately, fully insertedinto the uterus (e.g., when the distal tip 108 of the shaft 102 ispositioned adjacent the fundus, as will be discussed in more detail withrespect to FIG. 8). The ruler markings 124 may be provided in Englishunits (e.g., inches) or S.I. units (e.g., mm or cm).

The shaft 102 (e.g., including the section of the proximal portion 114extending from the manipulator handle 112, the central portion 116, andthe distal tip 108) typically has a length of about 11.0 inches to about12.0 inches (e.g., about 11.4 inches to about 11.7 inches. The sectionof the proximal portion 114 extending from the manipulator handle 112typically has a radius of curvature of about 5.0 inches to about 7.0inches (e.g., about 6.0 inches). The central portion 116 of the shaft102 typically has a radius of curvature of about 5.50 inches to about7.00 inches (e.g., about 6.00 inches to about 6.25 inches). The distaltip 108 of the shaft 102 typically has a length of about 0.50 inch toabout 0.60 inch (e.g., about 0.55 inch to about 0.56 inch). The shaft102 typically has an inner diameter of about 0.100 inch to about 0.150inch (e.g., about 0.128 inch to about 0.134 inch) and a wall thicknessof about 0.020 inch to about 0.040 inch (e.g., about 0.027 inch to about0.029 inch).

The expandable balloon 106 is secured at opposite ends to the distal tip108 of the shaft 102. The balloon 106 can be secured to the shaft 102via chemical bonding and compressive capture via the shrink tube. Theexpandable balloon 106 surrounds the opening 122 along the distal tip108 and accordingly is in fluid communication with the central lumen 120of the shaft 102. The expandable balloon 106 can be rapidly inflated andrapidly deflated by syringe actuation that occurs at the manipulatorhandle 112. The expandable balloon 106 typically has a length of about1.2 inches to about 1.8 inches (e.g., about 1.4 inches to about 1.6inches). In a fully inflated state, the expandable balloon 106 typicallyhas a maximum diameter of about 0.60 inch to about 0.80 inch (e.g.,about 0.66 inch to about 0.68 inch).

Still referring to FIG. 2, the light source 110 can be secured to thedistal tip 108 of the shaft 102 via crimping or chemical bonding and istypically provided as a light-emitting diode (LED). The light source110, together with the distal tip 108, forms an atraumatic surface thatallows the uterine manipulator 100 to be inserted in the patient withoutdamaging tissues of the vaginal cavity, cervix, or uterus. The lightsource 110 can be turned on and off by actuating a button 119 (e.g., apush button or a slidable button) that is disposed along the manipulatorhandle 112 and that is electrically coupled to the power source disposedwithin the manipulator handle 112. The button may generally be disposedalong a distal region of the manipulator handle 112 and may be optimallypositioned for a right-handed or left-handed user (e.g., a surgeon) ofthe uterine manipulator 100. Button actuation of the integral lightsource 110 can provide the user of the uterine manipulator 100 with asimple, ergonomic, and one-handed mechanism for increasing visibilityduring insertion of the uterine manipulator. The light source 110 canreceive power via the one or more electrical wires that extend withinthe central lumen 120 between the power source and the light source 110.The light source 110 typically operates (e.g., emits light) at a powerdissipation of about 100 mW to about 140 mW (e.g., about 108 mW to about132 mW).

Referring now to FIGS. 1 and 2, the manipulator handle 112 is formed asa clam shell structure that includes a female portion 126 and a maleportion 128. The female and male portions 126, 128, respectively,include multiple receptacles 130 (e.g., hexagonal shaped receptacles)and multiple pins (e.g., round or cylindrical shaped pins) positionedalong peripheral edges and aligned to mate with each other to hold thefemale and male portions 126, 128 together. The manipulator handle 112includes finger depressions 132, 134, 136 that provide a grip to allowthe user of the uterine manipulator 100 to ergonomically grip themanipulator handle 112. The manipulator handle 112 further includes anintegral syringe 138 for injecting air into and removing air from thecentral lumen 120 of the shaft 102 to inflate and deflate the expandableballoon 106 in fluid communication with the central lumen 120. A body140 of the syringe 138 extends distally from the manipulator handle 112and surrounds an end of the proximal portion 114 of the shaft 102, suchthat the shaft 102, surrounded by the shrink tube 118 along its proximalportion 114, terminates within the body 140 of the syringe 138. Thesyringe 138 further includes a plunger 142 that can be actuated (e.g.,slid proximally and distally) via a slidable button 144 to inject airinto and remove air from the central lumen 120 of the shaft 102. Thesyringe 138 further includes one or more internal detents in contactwith a bottom surface of the button 144 that serve to secure the button144 in a proximal or distal position upon the button 144 being slid pastthe detents. Button actuation of the integral syringe 138 can providethe user of the uterine manipulator 100 with a simple, ergonomic, andone-handed mechanism for inflating and deflating the expandable balloon106 during a surgical procedure.

The shaft 102, the expandable balloon 106, the manipulator handle 112,and the shrink tube 118 of the uterine manipulator 100 can be formed(e.g., molded and/or machined) from one or more materials that arebiocompatible and capable of withstanding medical device sterilizationprocedures, such as chemical-based methods or heat-based methods. Insome embodiments, the shaft 102 (e.g., including the proximal portion114, the central portion 116, and the distal tip 108) can be made of 304SS and/or 304 SS full hard. Such materials can advantageously providetactile feedback (e.g., resistance to movement of tissue) to the user ofthe uterine manipulator 100 as the shaft 102 is inserted or positionedwithin the patient. In some embodiments, the expandable balloon 106 canbe made of silicone, polyvinyl chloride (PVC) or a thermal plasticsrubber elastomer (TPRE). In some embodiments, the manipulator handle 112can be made of polycarbonate or Acrylonitrile butadiene styrene (ABS).In some embodiments, the shrink tube 118 can be made of acrylated olefinand can have a shore durometer of about shore D25 to about shore D60.Such a hardness can provide the shrink tube 118 with enough traction tolock the colpotomizer assembly 104 in a desired location, as will bediscussed in more detail with respect to FIGS. 3 and 4. While certainexamples of materials from which the shaft 102, the expandable balloon106, the manipulator handle 112, and the shrink tube 118 can be formedhave been provided, it should be understood that a variety of othermaterials can alternately be used to form these components.

Referring to FIGS. 1 and 3, the colpotomizer assembly 104 is adisplaceable assembly that may be slid along the shaft 102 of theuterine manipulator 100. The ability to displace the colpotomizerassembly 104 can allow for quicker and easier positioning of the distaltip 108 of the shaft 102 within the cervix since this procedure can beperformed without the visual obstruction of the colpotomizer assembly104. Then, once proper placement of the distal tip 108 is visuallyconfirmed, the colpotomizer assembly 104 can be advanced along the shaft102 into engagement with the cervix. The colpotomizer assembly 104includes a colpotomizer cup 146 adapted to receive the cervix, a sleeve148 that is connected to the colpotomizer cup 146 and that can begrasped for moving the colpotomizer assembly 104, and a vaginal occluder150 disposed about a distal cuff 196 of the sleeve 148.

Referring particularly to FIG. 3, the colpotomizer cup 146 includes anannular body 152, a rim 154 located at a distal end 156 of the body 152,and a base 158 located at a proximal end 160 of the body 152. The rim154 is beveled to permit anatomical landmark and incision backstopduring use of the uterine manipulator 100. The body 152 includes threeprojections 162 that extend to the base 158 and define three viewingwindows 164. The base 158 of the colpotomizer cup 146 defines an opening166 sized to allow passage of the shaft 102. As shown in FIG. 6, a wallof the opening 166 defines a cylindrical profile through which the shaft102 passes. Referring again to FIG. 3, the sleeve 148 extends proximallyfrom the base 158 of the colpotomizer cup 146 and has an arcuate shapethat generally follows the shape of the central portion 116 of the shaft102. The sleeve 148 is formed as a clam shell structure that includes afemale portion 168 and a male portion 170 (shown in FIG. 1). The femaleand male portions 168, 170, respectively, include multiple receptacles172 (e.g., hexagonal shaped receptacles) and multiple pins (e.g., roundor cylindrical shaped pins) positioned along peripheral edges andaligned to mate with each other to secure the female and male portions168, 170 together. The female and male portions 168, 170 together definea channel 111 through which the shaft 102 extends.

At a proximal end 174 of the sleeve 148, the sleeve 148 includes a thumblock 176, opposing receptacles 178 that receive the thumb lock 176,opposing projections 180 to which the thumb lock 176 can be snap fitted,and a guide surface 182 that appropriately guides the sleeve 148 alongthe shaft 102 and supports the shaft 102 for contact with the thumb lock176. The thumb lock 176, receptacles 178, projections 180, and guidesurface 182 together provide a quick, one-handed locking mechanism thatallows the colpotomizer assembly 104 to be locked into a desiredposition along the shaft 102.

Referring to FIGS. 3 and 4, the thumb lock 176 includes a cam roller 184adapted to contact the shrink tube 118 surrounding the shaft 102 to lockthe colpotomizer assembly 104 into a selected position along the shaft102. In particular, the radius of the cam roller 184 is variable (e.g.,extending radially beyond a minimum circumference of the cam roller 184along certain portions of the cam roller 184), such that the cam roller184 compresses (e.g., digs into) the shrink tube 188 as the cam roller184 is rotated towards the shaft 102 of the uterine manipulator 100. Thethumb lock 176 further includes a roller mount 186 adjacent the camroller 184, a jaw 188 extending from the cam roller 184, a lens 190disposed atop the jaw 188, and a lift flange 192 extending proximallyfrom the jaw 188. The lens 190 is a convex lens that magnifies the rulermarkings 124 printed along the shaft 102. The focal point of the lens190 is selected such that a ruler marking 124 substantially fills theviewing window of the lens 190. Such magnification assists the user ofthe uterine manipulator 100 in visualizing the ruler markings 124 todetermine the position of the colpotomizer assembly 104 along the shaft102. The roller mount 186 is adapted to extend into and rotate withinthe receptacles 178.

The thumb lock 176 allows the colpotomizer assembly 104 to be lockedinto a desired position using an easy, one-handed technique that can becarried out with the same hand that moves the colpotomizer assembly 104along the shaft 102. When the lens 190 or the lift flange 192 is pusheddownward (e.g., by the user's thumb) towards the shaft 102 to place thethumb lock 176 in a closed configuration (shown in FIG. 4), rotation ofthe roller mount 186 and associated rotation of the cam roller 184causes the cam roller 184 to dig into the shrink tube 118, therebygenerating friction that locks the sleeve 148 of the colpotomizerassembly 104 in position along the shaft 102. The cam roller 184 of thethumb lock 176 is configured to apply a compressive load of up to about5 lb to about 10 lb (e.g., about 7 lb to about 8 lb) on the shaft 102.Such downward force applied to the lens 190 or to the lift flange 192also causes the jaw 188 to snap fit onto the projections 180. When thelift flange 192 is pushed upward (e.g., by the user's thumb) away fromthe shaft 102 to place the thumb lock 176 in an open configuration(shown in FIG. 3), rotation of the roller mount 186 and associatedrotation of the cam roller 184 causes the cam roller 184 to release theshrink tube 118, thereby unlocking the sleeve 148 of the colpotomizerassembly 104 with respect to the shaft 102. Such upward force applied tothe lift flange 192 also causes the jaw 188 to separate from theprojections 180. The thumb lock 176 provides the user with the abilityto lock the colpotomizer assembly 104 at various different positionsalong the shaft 102 of the uterine manipulator 100.

As shown in FIG. 5, the vaginal occluder 150 includes a main body 194that can be mounted concentrically about the distal cuff 196 of thesleeve 148, an expandable balloon cuff 198, and a balloon cuff cathetertube 101. The balloon cuff catheter tube 101 is affixed to the ballooncuff 198 and communicates fluid to the balloon cuff 198 when inflationis desired.

Referring to FIGS. 6 and 7, the colpotomizer assembly 104 of the uterinemanipulator 100 has a geometry (e.g., provided by the position and sizeof the opening 166 of the base 158) that ensures proper alignment of thecup face 103 with respect to the shaft 102. The cup face 103 is orientedperpendicular (e.g., normal) to an axial centerline 109 of thecolpotomizer cup 146. A centerpoint 105 of the cup face 103 (locatedalong the axial centerline 109 of the colpotomizer cup 146) ismaintained along an arch centerline 107 of the shaft 102 as thecolpotomizer assembly 104 is slid along the shaft 102. Such alignment ofthe cup face 103 with the arch centerline 107 is provided by an offset113 between the centerline 109 of the colpotomizer cup 146 and the archcenterline 107 of the shaft 102, at the location of the opening 166 ofthe base 158 of the colpotomizer cup 146. The offset 113 is typically adistance of about 0.065 inch to about 0.085 inch (e.g., about 0.071 inchto about 0.081 inch). The colpotomizer cup 146 is substantiallyprevented from tilting with respect to the shaft 102 by points ofcontact between the cup 146 and the shaft 102 at the opening 166 of thebase 158 and the roller mount 182 and cam lock 184 of the thumb lock176. Aligning the colpotomizer cup 146 with respect to the shaft 102 inthis manner ensures that an appropriately angled cutting edge isachieved for guiding a cutting of the uterus with an even distributionof tissue when the cervix is received within the colpotomizer cup 146.In other words, this configuration can help to ensure that substantiallythe same amount of cervical tissue is received in the colpotomizer cup146 about the entire circumference of the shaft 102, and can thus helpto ensure that a symmetrical cut is made to the cervix during a surgicalprocedure, such as a hysterectomy.

The various components of the colpotomizer assembly 104 can be formed(e.g., molded and/or machined) from one or more materials that arebiocompatible. In some embodiments, the colpotomizer cup 146 can be madeof polyetherimide (PEI). In some embodiments, the female and maleportions 168, 170 of the sleeve 148 can be made of acrylonitrilebutadiene styrene (ABS). In some embodiments, certain components of thethumb lock 176 (e.g., the cam roller 184, the roller mount 186, the jaw188, and the lift flange 192) can be made of polycarbonate. In someembodiments, the various components of the vaginal occluder 150 can bemade of medical grade silicone. In some embodiments, the colpotomizercup 146 and the sleeve 148 are formed (e.g., molded) as separate itemsthat can then be connected together (e.g., via press fit or snap fit).This two-piece assembly can allow cup bodies of different sizes (e.g.,different diameters) to be used with the same sleeve. While certainexamples of materials with which the components of the colpotomizerassembly 104 can be formed have been described, it should be understoodthat other materials can alternately be used to form these components.

Referring to FIG. 8, in some embodiments, the uterine manipulator 100 isprovided as a disposable (e.g., single-use) surgical device that ishoused in a packaging container 200. The packaging container 200provides an easy-to-open structure that allows for secure, space-savingtransport and storage of the uterine manipulator 100. The packagingcontainer 200 includes a base 202 that houses the uterine manipulator100 and a cover 204 that can be peeled from the base 202 to open thepackaging container 200. The base 202 of the packaging container 200 hasa shape that generally follows the shape of the uterine manipulator 100.The base 202 of the packaging container 200 includes spaced apart posts206 that secure the shaft 102 of uterine manipulator 100 in a stableposition. The packaging container 200 can be transparent, translucent,or opaque and can be made of one or more materials that arebiocompatible. For example, the packaging container 200 can be made ofEthylene-vinyl acetate.

The uterine manipulator 100 may be used in a number of procedures thatrequire manipulation of the uterus, including surgical procedures, suchas hysterectomies. In one example, the uterine manipulator 100 is usedin a total laparoscopic hysterectomy (TLH) surgery. A patient isprepared for TLH surgery according to know procedures. Such procedurescan include determining a depth of the uterus (e.g., as measured fromthe fundus of the uterus to the cervical os) using a sounding device oran ultrasound technique. For example, a sounding device that has rulermarkings along its length may be inserted into the patient until adistal end is positioned adjacent the fundus of uterus according tovisual confirmation of the depth reading at the cervix. The rulermarking located at the depth of the uterus (i.e., at the proximal end ofthe cervix) indicates the location where the colpotomizer cup 146 of thecolpotomizer assembly 104 should be placed during the surgicalprocedure. In other words, the depth of the uterus corresponds to anoperational position of the colpotomizer cup 146 for carrying out theprocedure. As discussed above with respect to FIGS. 2-4, the rulermarkings 124 along the shaft 102 of the uterine manipulator 100 indicatea distance from the fundus to the base 158 of the colpotomizer cup 146when the uterine manipulator 100 is appropriately, fully inserted withinthe patient. The ruler markings 124 along the shaft 102 compensate foran arc length of the colpotomizer assembly 104, thereby reflecting anaccurate depth placement of the colpotomizer cup 146. Proper placementof the uterine manipulator 100 with respect to the fundus, as aided bythe lens 190 of the thumb lock 176 and the ruler markings 124 along theshaft 102, can prevent perforation and other damage to the fundus andthe distal region of the uterus.

FIGS. 9-12 illustrate a method of using the uterine manipulator 100.Referring particularly to FIG. 8, once prepared, the patient'speritoneal cavity 300 is inflated with a gas (e.g., CO2) to facilitateaccessibility and visibility of the female pelvic organs and surgicalinstruments (e.g., a laparoscope 314) as the instruments are insertedthrough the abdominal wall 302 and into the peritoneal cavity 300. Thecolpotomizer assembly 104, while in an unlocked configuration, is slidproximally along the shaft 102 until the colpotomizer assembly 104reaches a loading position (e.g., a position where the proximal end 174of the sleeve 148 is positioned along the proximal portion 114 of theshaft 102). The button 119 located along the manipulator handle 112 forcontrolling the light source 110 is actuated (e.g., depressed or slid)to turn on the light source 110. Next, the uterine manipulator 100, withthe colpotomizer assembly 104 in the loading position and with the lightsource 110 turned on, is inserted into the vaginal cavity 304. Lightemitted from the light source 110 improves visibility of the vaginalcavity 304 as the uterine manipulator 100 is inserted. In some cases,the colpotomizer assembly 104 is locked in the loading position prior toinsertion into the vaginal cavity 304. In other instances, thecolpotomizer assembly 104 remains unlocked in the loading positionduring insertion into the vaginal cavity 304.

Referring to FIG. 10, the uterine manipulator 100 is moved distallywithin the vaginal cavity 304 until the distal tip 108 of the shaft 102is positioned adjacent the fundus 308 of the uterus. The slidable button144 of the syringe 138 is then slid distally (as shown in FIG. 2) toinflate the expandable balloon 106 such that the expandable balloon 106engages an interior surface of the uterus 306. In some cases, theslidable button 144 may be slid proximally to deflate the expandableballoon 106 if it is determined that the uterine manipulator 100 needsto be repositioned. Leaving the colpotomizer assembly 104 in the loadingposition during insertion of the uterine manipulator 100 can allow for arelatively unobstructed view of the cervix 310 to help ensure properplacement of the distal tip 108 of the shaft 102.

Referring to FIG. 11, the colpotomizer assembly 104 (still in theunlocked configuration) is advanced distally from the loading positionuntil the ruler markings 124 (as visualized through the lens 190)indicate that the base 158 of the colpotomizer cup 146 is positioned atan operational position (i.e., at a distance from the distal tip 108that is approximately equal to the depth of the uterus 306 as determinedfrom the sounding device). The viewing windows 164 of the colpotomizercup 146 can provide for additional visual confirmation of placement. Inthe operational position, the cervix 310 is positioned within the body152 of the colpotomizer cup 146 and abuts the base 158 of thecolpotomizer cup 146. The alignment of the lens 190 with the rulermarking 124 and the ability to view placement of the cervix 310 withinthe colpotomizer cup 146 through the viewing windows 164 helps to ensurethat the colpotomizer cup 146 is fully forward in the desired positionrelative to the distal tip 108 of the shaft 102 and relative to thecervix 310. In this position, the colpotomizer cup 146 provides ananatomical landmark at the base of the uterus 306 (e.g., indicating alocation of an apex of the cervix 310) and an incision backstop (e.g.,an edge that defines where the uterus 306 should be cut). Furthermore,the cup face 103 of the colpotomizer cup 146 is centered on the archcenterline 107 of the shaft 102, ensuring a proper angular position ofthe colpotomizer cup 146 with respect to the shaft 102 for providing adesirable or suitable cutting guide.

With the colpotomizer assembly 104 positioned as desired, the jaw 188 ofthe thumb lock 176 is then depressed to lock the colpotomizer assembly104 at the operational position. The jaw 188 can be depressed using thesame hand that advances the colpotomizer assembly 104 within the vaginalcavity 304, such that distal movement and locking of the colpotomizerassembly 104 can be performed in a one-handed operation. If necessary,the lift flange 192 of the thumb lock 176 can be pushed upwards tounlock the colpotomizer assembly 104 for repositioning along the shaft102. In some implementations, the mechanical integrity of the thumb lock176 may be maintained over multiple (e.g., four) lock-unlock cycles.

Referring to FIG. 12, once the colpotomizer assembly 104 is locked inthe desired operational position along the shaft 102, the vaginaloccluder 150 can be inflated (e.g., with a sterile, water-based fluid)to seal a distal region of the vaginal cavity 304, thereby maintainingpneumoperitoneum. The vaginal occluder 150 inhibits (e.g., prevents) theescape of gas used to inflate the peritoneal cavity 300 during andfollowing the first of any colpotomy incisions.

A surgeon can then manipulate or move the uterus 306 into a desiredposition to perform surgical procedures that include cutting around thebase of the uterus 306. As discussed above, the offset 113 (located atthe opening 166 in the base 158 of the colpotomizer cup 146) between thecenterline 109 of the colpotomizer cup 146 and the arch centerline 107of the shaft 102 ensures that the centerpoint 105 of the cup face 103 islocated along the arch centerline 107 of the shaft 102. Such aconfiguration prevents undesired tilting of the colpotomizer cup 146relative to the shaft 102, such that cutting along the cup face 103results in a symmetrical cut of the uterus 306 with an even distributionof tissue within the colpotomizer cup 146. After the uterus 306 iscompletely incised such that the uterus 306 is totally free in theperitoneal cavity 300 and held only by the uterine manipulator 100, thenthe uterine manipulator 100, along with the supported uterus 306, isremoved through the vaginal cavity 304. The uterine manipulator 100 canbe disposed of following the surgery.

While certain embodiments have been described above, other embodimentsare possible.

For example, while the locking mechanism of the colpotomizer assembly104 is described as being located at the proximal end 174 of the sleeve148, in other embodiments, a locking mechanism may be located adifferent location (e.g., at an intermediate location) along a length ofa colpotomizer assembly.

While a specific configuration of a one-handed cam-based lockingmechanism has been described, other types of locking mechanisms can beused. In certain embodiments, for example, a uterine manipulator mayinclude a different type of one-handed cam-based locking mechanism. Suchexample locking mechanisms may include a screen door mechanism, a TouhyBorst mechanism, or a sheet metal skive capture mechanism.

While the colpotomizer assembly 104 has been described as including aone-handed locking mechanism, in some embodiments, a uterine manipulatormay include a colpotomizer assembly that has a two-handed lockingmechanism.

While the uterine manipulator 100 has been described as including theintegral syringe 138, in some embodiments, a uterine manipulator may notinclude an integral syringe. For example, in some embodiments, a syringemay alternatively be secured externally to a proximal end of amanipulator handle of a uterine manipulator.

While the uterine manipulator 100 has been described as including theintegrated light source 110, in some embodiments, a uterine manipulatormay not include an integrated light source. For example, in someembodiments, a uterine manipulator may be used with a separate orexternal light source. In other examples, a uterine manipulator may beused without a light source.

While the uterine manipulator 100 has been described as disposable, insome embodiments, the uterine manipulator 100 may be reusable (e.g.,sterilizable).

What is claimed is:
 1. A uterine manipulator, comprising: a shaftconfigured to be inserted into a cervix, the shaft comprising aplurality of ruler markings printed along a portion of the shaft; and acolpotomizer assembly configured to move along the shaft, thecolpotomizer assembly comprising a sleeve that comprises a rotatablelocking member configured to compress the shaft in a manner that locksthe colpotomizer assembly in position along the shaft when the rotatablelocking member is depressed against the shaft, the rotatable lockingmember comprising a cam roller configured to compress the shaft when therotatable locking member is depressed towards the shaft.
 2. The uterinemanipulator of claim 1, wherein the shaft is a rigid shaft.
 3. Theuterine manipulator of claim 1, further comprising a shrink tube thatsurrounds a portion of the shaft, such that when the rotatable lockingmember is depressed towards the shaft, the rotatable locking membercompresses the shrink tube.
 4. The uterine manipulator of claim 3,wherein the shrink tube has a hardness of about shore D25 to about shoreD60.
 5. The uterine manipulator of claim 1, wherein the sleeve defines achannel configured to receive the shaft.
 6. The uterine manipulator ofclaim 1, wherein the rotatable locking member comprises a lensconfigured to magnify a ruler marking of the plurality of ruler markingswhen the rotatable locking member is depressed against the shaft.
 7. Theuterine manipulator of claim 1, wherein the rotatable locking membercomprises a roller mount that extends from the cam roller, and whereinthe sleeve defines a receptacle configured to receive the roller mountof the rotatable locking member.
 8. The uterine manipulator of claim 1,wherein the sleeve comprises opposing projections, and the rotatablelocking member comprises a jaw configured snap fit onto the opposingprojections for securing the rotatable locking member in a lockedconfiguration.
 9. The uterine manipulator of claim 1, wherein therotatable locking member comprises a lift flange for rotating therotatable locking member away from the shaft and into an openconfiguration.
 10. The uterine manipulator of claim 1, wherein theplurality of ruler markings indicates a distance between a base of a cupof the colpotomizer assembly and a distal end of the shaft.
 11. Theuterine manipulator of claim 1, wherein the colpotomizer assemblyfurther comprises a cup configured to receive the cervix and that isattached to the sleeve.
 12. The uterine manipulator of claim 1, whereinthe cup is configured such that a distal face of the cup remainscentered on an arch centerline of the shaft as the colpotomizer assemblyis moved along the shaft and such that an axial centerline of the cupremains offset from the arch centerline of the shaft at an opening ofthe cup that is spaced proximally from the distal face of the cup. 13.The uterine manipulator of claim 1, wherein the colpotomizer assemblyfurther comprises a vaginal occluder.
 14. The uterine manipulator ofclaim 11, further comprising a manipulator handle.
 15. The uterinemanipulator of claim 14, wherein the manipulator handle comprises anintegrated syringe configured to displace air within a central lumen ofthe shaft.
 16. The uterine manipulator of claim 15, further comprisingan expandable balloon disposed along a distal tip of the shaft and influid communication with the central lumen of the shaft.
 17. The uterinemanipulator of claim 16, wherein the integrated syringe is configured todeliver air to and withdraw air from the expandable balloon.
 18. Theuterine manipulator of claim 1, further comprising an integrated lightsource mounted to a distal tip of the shaft.
 19. The uterine manipulatorof claim 18, wherein the manipulator handle comprises a power source forpowering the integrated light source.
 20. The uterine manipulator ofclaim 1, wherein the uterine manipulator is a single-use device.
 21. Acolpotomizer assembly configured to move along a shaft of a uterinemanipulator, the colpotomizer assembly comprising a sleeve thatcomprises a rotatable locking member configured to compress the shaft ina manner that locks the colpotomizer assembly in position along theshaft when the rotatable locking member is depressed against the shaft,the rotatable locking member comprising a cam roller configured tocompress the shaft when the rotatable locking member is depressedtowards the shaft.
 22. The colpotomizer assembly of claim 21, whereinthe sleeve defines a channel that surrounds the shaft.
 23. Thecolpotomizer assembly of claim 21, wherein the rotatable locking membercomprises a lens configured to magnify a ruler marking printed along theshaft when the rotatable locking member is depressed against the shaft.24. The colpotomizer assembly of claim 23, wherein the ruler markingindicates a distance between a base of a cup of the colpotomizerassembly and a distal end of the shaft.
 25. The colpotomizer assembly ofclaim 21, wherein the rotatable locking member comprises a roller mountthat extends from the cam roller, and wherein the sleeve defines areceptacle configured to receive the roller mount of the rotatablelocking member.
 26. The colpotomizer assembly of claim 21, wherein thesleeve comprises opposing projections, and the rotatable locking membercomprises a jaw configured snap fit onto the opposing projections forsecuring the rotatable locking member in a locked configuration.
 27. Thecolpotomizer assembly of claim 21, wherein the rotatable locking membercomprises a lift flange for rotating the rotatable locking member awayfrom the shaft and into an open configuration.
 28. The colpotomizerassembly of claim 21, further comprising a cup configured to receive acervix and that is attached to the sleeve.
 29. The colpotomizer assemblyof claim 21, wherein the cup is configured such that a distal face ofthe cup remains centered on an arch centerline of the shaft as thecolpotomizer assembly is moved along the shaft and such that an axialcenterline of the cup remains offset from the arch centerline of theshaft at an opening of the cup that is spaced proximally from the distalface of the cup as the cup is moved along the shaft.
 30. The uterinemanipulator of claim 21, wherein the colpotomizer assembly furthercomprises a vaginal occluder.
 31. A method of adjusting a uterinemanipulator, comprising: moving a colpotomizer sleeve of the uterinemanipulator to a predetermined position along a shaft of the uterinemanipulator; depressing a rotatable locking member of the colpotomizersleeve towards the shaft; compressing the shaft with the rotatablelocking member of the colpotomizer sleeve to lock the colpotomizersleeve at the predetermined location; and confirming an accuracy of theposition of the colpotomizer sleeve by visualizing a ruler markingprinted along the shaft using a magnification lens of the rotatablelocking member.
 32. The method of claim 31, wherein the colpotomizersleeve defines a channel configured to receive the shaft.
 33. The methodof claim 31, wherein compressing the shaft with the rotatable lockingmember comprises rotating a cam roller of the rotatable locking memberinto a shrink tube surrounding the shaft.
 34. The method of claim 33,wherein depressing the rotatable locking member towards the shaftcomprises rotating a roller mount of the rotatable locking member withinreceptacles of the colpotomizer sleeve.
 35. The method of claim 31,wherein compressing the shaft with the rotatable locking membercomprises snap fitting a jaw of the rotatable locking member ontoopposing projections of the colpotomizer sleeve for securing therotatable locking member in a locked configuration.
 36. The method ofclaim 31, further comprising moving a lift flange of the rotatablelocking upwards for rotating the rotatable locking member away from theshaft and into an open configuration.
 37. The method of claim 31,wherein the ruler marking indicates a distance between a base of acolpotomizer cup secured to the colpotomizer sleeve and a distal end ofthe shaft.
 38. The method of claim 31, wherein moving the colpotomizersleeve along the shaft comprises moving a colpotomizer cup configured toreceive a cervix and that is attached to the colpotomizer sleeve. 39.The method of claim 38, wherein the colpotomizer cup is configured suchthat a distal face of the colpotomizer cup remains centered on an archcenterline of the shaft as the colpotomizer cup is moved along the shaftand such that an axial centerline of the cup remains offset from thearch centerline of the shaft at an opening of the cup that is spacedproximally from the distal face of the cup as the colpotomizer cup ismoved along the shaft.
 40. The method of claim 31, wherein the moving,the depressing, and the compressing is performed in a one-handedprocess.